Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer (GIP-1)

Istituti Tumori Giovanni Paolo II

Status and phase: Unknown; Phase 3

Conditions: Pancreatic Cancer

Treatments: Drug: gemcitabine; Drug: cisplatin

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00813696

GIP-1

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.

Enrollment: 400 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic or cytologic diagnosis pancreatic cancer
• inoperable stage II or stage III or IV disease(UICC, 1997)
• Age 18 to 75 years
• Karnofsky Performance status > 50
• Signed informed consent

Exclusion criteria

• Previous chemotherapy
• Cerebral metastases
• Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer
• Leukocytes < 4000 or neutrophils < 2000 or platelets < 100000 or hemoglobin < 10 g/dl
• Creatinine value > upper normal limit
• GOT or GPT > 2.5 times upper normal limit or bilirubin > 1.5 times upper normal limit in absence of hepatic metastases
• Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease
• Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs
• Inability to provide informed consent
• Inability to comply with follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

A

Experimental group

Description:

cisplatin + gemcitabine

Treatment:

Drug: gemcitabine

Drug: cisplatin

B

Active Comparator group

Description:

gemcitabine

Treatment:

Drug: gemcitabine